Apparatus and methods for sealing a puncture in tissue

ABSTRACT

An occlusion device for sealing a puncture through tissue includes a tubular wire member having a proximal end, a distal end sized for insertion into the puncture, a lumen extending between the proximal and distal ends, a port adjacent the proximal end communicating with the 5 lumen, and a balloon on the distal end. A source of fluid is connectable to the wire member for delivering fluid via the port into the lumen for expanding the balloon. A fluid loading device is disposed on the proximal end of the wire member to receive the source of fluid and to deliver fluid within the lumen into the balloon to expand the balloon.

RELATED APPLICATION DATA

This application is a continuation of co-pending application Ser. No.11/112,877, filed Apr. 22, 2005, issuing as U.S. Pat. No. 8,002,742, theentire disclosure of which is expressly incorporated by referenceherein.

FIELD OF INVENTION

The present invention relates generally to apparatus and methods forsealing punctures in a body, to apparatus and methods for facilitatingaccess through a puncture extending through tissue, and, moreparticularly, to apparatus and methods for deploying an occlusionelement, such as a balloon or other expandable member, disposed on aguidewire or other flexible elongate member, to seal a puncture throughtissue.

BACKGROUND

Apparatus and methods are known for accessing a patient's vasculaturepercutaneously for performing a procedure within the vasculature. Forexample, a hollow needle may be inserted through a patient's skin andoverlying tissue into a blood vessel. A guidewire is then passed throughthe needle into the blood vessel, whereupon the needle is removed. Anintroducer sheath is then advanced over the guidewire into the vessel,e.g., in conjunction with or subsequent to one or more dilators. Acatheter or other device may be advanced through the introducer sheathand over the guidewire into a position for performing a medicalprocedure within the patient's body. In this manner, the introducersheath facilitates introducing various instruments into the vessel,while minimizing trauma to the vessel wall and blood loss.

Upon completing the procedure, the instrument(s) and introducer sheathare removed, leaving a puncture extending between the skin and thevessel. To seal the puncture, external pressure may be applied to theoverlying tissue, e.g., manually and/or using sandbags, until hemostasisoccurs. This procedure, however, can be time consuming and expensive,requiring as much as an hour of a medical professional's time. It isalso uncomfortable for the patient, and may require the patient toremain immobilized in an operating room, catheter lab, or holding area.In addition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus and methods have been suggested for sealing apercutaneous puncture instead of or in addition to using externalpressure. For example, U.S. Pat. No. 5,108,421 to Fowler discloses usinga collagen plug that is delivered into a puncture through tissue. Aftercompleting the procedure, the introducer sheath and/or guidewire used toaccess the patient's vasculature via the puncture are removed. In oneembodiment, a catheter is inserted through the puncture into the bloodvessel. A balloon on the catheter is expanded and then retracted untilthe balloon is disposed adjacent the puncture at the wall of the vessel.A plug is then advanced into the puncture until the plug contacts theballoon, thereby preventing the plug from entering the vessel. Once theplug is positioned within the puncture, the balloon is deflated andwithdrawn, leaving the plug to expand and seal the puncture and/orpromote hemostasis.

By way of another example, U.S. Pat. Nos. 5,192,302 and 5,222,974 issuedto Kensey et al. describe using a collagen plug that may be deliveredthrough an introducer sheath into a puncture site.

Such sealing methods generally involve introducing plugs or othermaterials into the puncture after completing the procedure and removingthe introducer sheath. With the introducer sheath removed, there issubstantial risk of hematoma within the tissue surrounding the punctureas blood from the vessel leaks into the puncture, which may beuncomfortable and/or harmful to the patient. Further, temporaryhemostasis devices for isolating the vessel from the puncture may bedifficult to use effectively and/or may be expensive. Despite attemptsto isolate the vessel from the puncture while delivering a plug or othersealing material, the sealing material may still leak and/or becomeexposed in the vessel, where the sealing material may risk causing anembolism in the vessel.

SUMMARY OF THE INVENTION

The present invention is directed generally to apparatus, systems, andmethods for facilitating access through a puncture through tissue, e.g.,extending from a patient's skin to a blood vessel or other body lumen,and/or for sealing such punctures. More particularly, apparatus andsystems are provided that include a guidewire or other elongate tubularmember having a balloon or other expandable member thereon, and methodsfor using such tubular members are also provided.

Generally, the expandable member may be expanded and/or collapsed bymoving a piston within the tubular member to direct fluid into and/orout of the expandable member. In addition or alternatively, theexpandable member may be inflated and/or deflated using a fluiddispensing device communicating with the lumen of the tubular member,e.g., that may be removably coupled to the tubular member.

In one embodiment, an occlusion member is provided for sealing apuncture. Generally, the occlusion member includes an elongate tubularmember including a proximal end, a distal end, a lumen extending atleast partially between the proximal and distal ends, and an expandableocclusion element disposed on a distal region of the tubular member. Apiston may extend from and/or be movable within the lumen of the tubularmember for directing fluid within the lumen into and/or out of theocclusion member. Such that movement of the piston relative to thetubular member may inflate and expand and/or deflate and collapse theocclusion element.

In another embodiment, a balloon wire device is provided for sealing apuncture through tissue. Generally, the device includes an elongatetubular or wire member including a proximal end, and a distal end sizedand shaped for insertion into a puncture through tissue, e.g., having aprofile similar to a conventional guidewire. The device includes a lumenextending axially through the wire member, and a balloon or otherexpandable member on a distal region of the wire member. The wire membermay include one or more openings, e.g., in a proximal region of the wiremember, that communicates with the lumen.

Optionally, the device may include a fluid dispensing device removablycoupled to the wire member. When the fluid dispensing device is coupledto the device, fluid may be directed from the fluid dispensing deviceinto lumen of the wire member via the opening(s) in the proximal end ofthe wire member. In one embodiment, the device may include a piston orother element movable within the wire member for facilitating deliveryof the fluid and/or for expanding and/or collapsing the expandablemember.

In another embodiment, a wire may be disposed inside the lumen having afirst end affixed to the proximal end of the wire member and a secondend affixed to the occlusion member. As the occlusion member isexpanded, e.g., by delivering fluid into the occlusion member via thelumen of the wire member, the wire may be subjected to a compressivestress, causing the wire to buckle. Conversely, as the occlusion memberis collapsed, e.g., by evacuating the fluid, the wire may extend axiallyto release the buckling stress, thereby extending the occlusion memberas it collapses. In one embodiment, the wire may be formed from anelastic or superelastic material, allowing the wire to resilientlybuckle and extend.

In yet another embodiment, a system is provided for introducing one ormore instruments into a body lumen of a patient through a punctureextending from the patient's skin to the body lumen. Generally, thesystem includes a balloon wire or other occlusion member, such as thosedescribed above. In addition, the system may include a fluid dispensingdevice, an assembly for delivering a sealing compound into the puncture,and/or an introducer sheath.

The fluid dispensing device may be removably coupled to the occlusionmember, e.g., for delivering fluid from the fluid dispensing device intoa lumen of the occlusion member. The introducer sheath may include aproximal end, a distal end sized and shaped for insertion into thepuncture, and a lumen extending between the proximal end and an openingin the distal end.

In accordance with another embodiment, a method is provided for sealinga puncture in a vessel using an occlusion member including an elongatetubular or wire member having a proximal end, a distal end, a lumenextending at least partially therebetween, and an expandable occlusionmember on a distal region of the tubular member.

Generally, the distal end of the tubular member is introduced into apuncture through tissue with the occlusion member collapsed, e.g., untilthe occlusion member is disposed within a body lumen communicating withthe puncture. A piston within the tubular member is moved to deliverfluid within the tubular member into the occlusion member, causing theocclusion member to expand. The tubular member may be at least partiallyretracted until the expanded occlusion member substantially seals thebody lumen from the puncture.

In another embodiment, a method is provided for sealing a puncture in awall of a blood vessel or other body lumen using an occlusion memberincluding an elongate tubular member and an expandable occlusion memberon a distal region of the tubular member. A fluid dispensing device maybe coupled or otherwise provided on a proximal end of the tubularmember. The distal end of the tubular member may be introduced throughthe puncture with the occlusion member collapsed. Fluid may be dispensedinto the tubular member from the fluid dispensing device to expand theocclusion member. The expanded occlusion member may be retracted againstthe wall of the body lumen to substantially seal the puncture.

In accordance with still another aspect of the invention, a method isprovided for preparing an occlusion member, the occlusion membercomprising an elongate tubular member including a proximal end, a distalend having an inflatable occlusion element thereon, a lumen extendingbetween the proximal and distal ends communicating with an interior ofthe occlusion element, and an opening at an intermediate location on thetubular member communicating with the lumen. In one embodiment, themethod includes advancing a distal end of an elongate member into theproximal end of the tubular member until the distal end of the elongatemember is disposed proximal to the opening and a proximal end of theelongate member extends proximally from the tubular member; evacuatingair from within the lumen and the interior of the occlusion member viathe opening; delivering a substantially incompressible inflation mediainto the lumen without substantially expanding the occlusion element;and advancing the distal end of the elongate member distally beyond theopening to substantially isolate the lumen with the fluid thereinwithout substantially expanding the occlusion element. The method mayfurther include advancing the elongate member distally within thetubular member to expand the occlusion element.

Other aspects and features of the invention will become apparent fromconsideration of the following description taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1 is a side view of a system for sealing a puncture, including anintroducer sheath, an occlusion member, a delivery sheath, and a syringeassembly for delivering sealing compound via the delivery sheath.

FIGS. 2A and 2B are cross-sectional side views of the occlusion memberof FIG. 1, showing a method for assembling the occlusion member.

FIGS. 2C and 2D are cross-sectional details of the occlusion member ofFIG. 1, showing a fluid dispensing device for delivering fluid into awire member of the occlusion member.

FIGS. 3A-3C are cross-sectional views of a patient's body, illustratinga method for delivering a sealing compound a puncture extending betweenthe patient's skin and a blood vessel.

FIGS. 4A-4C are cross-sectional views of a patient's body, showing amethod for delivering a sleeve and introducer sheath into the punctureof FIGS. 3A-3C after delivering a sealing compound therein.

FIGS. 5A and 5B are cross-sectional side views of another embodiment ofan occlusion member including a balloon in an expanded (i.e., deployed)state and a collapsed (i.e., un-deployed) state, respectively.

FIG. 6 is a cross-sectional side view of a fluid dispensing device andassociated syringe for inflating and/or deflating the balloon of FIGS.5A and 5B.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Turning to the drawings, FIG. 1 shows an exemplary embodiment of asystem 10 for accessing and/or delivering sealing compound into apuncture through tissue, e.g., a percutaneous puncture communicatingfrom a patient's skin through intervening tissue to a blood vessel orother body lumen (not shown). Generally, the system 10 includes adelivery or injection sheath 12, a source of sealing compound 14, and anocclusion member 16. Optionally, the system 10 may include othercomponents, e.g., an introducer or procedure sheath 18 (separate fromthe delivery sheath 12), and one or more dilators (an exemplary dilator19 being shown). The system 10 may also include one or more of a needlefor creating the puncture, a guidewire, and/or one or more sections oftubing (not shown). In addition or alternatively, the system 10 mayinclude other components for creating the puncture, introducing thedelivery sheath 12 and/or guidewire into a body lumen, and/or accessingthe vessel, e.g., for introducing instruments (not shown) into thevessel via the puncture.

Generally, the delivery sheath 12 is an elongate tubular member,including a proximal end 22, a distal end 24, and a primary or guidewirelumen 26 extending between the proximal and distal ends 22, 24. Inaddition, the delivery sheath 12 may include one or more secondary orinjection lumens 30 that extend from the proximal end 22 to one or moreoutlets (e.g., two outlets 31, as shown) in the wall of the deliverysheath 12.

As shown, a single secondary lumen 30 is disposed concentrically aroundthe primary lumen 26. Alternatively, one or more secondary lumens (notshown) may be formed or otherwise provided in the wall of the deliverysheath 12, e.g., in a side-by-side arrangement. The primary lumen 26 maybe of sufficient size to accommodate sliding a guidewire therethrough,e.g., between about 0.014 and 0.018 inch (0.35-0.45 mm) diameter, whilethe secondary lumen 30 may be of sufficient size to accommodatedelivering sealing compound therethrough.

The secondary lumen 30 extends from a housing 28 on the proximal end 22of the delivery sheath 12 to an intermediate portion 25 between theproximal and distal ends 22, 24. As shown, the intermediate portion 25tapers where the secondary lumen 30 terminates, with the delivery sheath12 having a smaller diameter from the intermediate portion 25 to thedistal end 24 (e.g., since only the primary lumen 26 extends along thisportion of the delivery sheath 12). The smaller diameter distal portionmay have a desired length, e.g., at least about five millimeters (5 mm).The outlet(s) 31 may be provided on the intermediate portion 25, e.g.,where the delivery sheath 12 tapers, which may facilitate directing thesealing compound delivered through the secondary lumen 30 radiallyoutwardly away from the delivery sheath 12.

The housing 28 may be attached to or otherwise provided on the proximalend 22 of the delivery sheath 12. The housing 28 may include one or moreside ports (e.g., one side port 32, as shown) that communicate with aninterior of the housing 28 and the secondary lumen 30 of the deliverysheath 12. The housing 28 may include one or more seals 29 to seal theinterior of the housing 28, e.g., such that sealing compound deliveredfrom the side port 32 may be directed through the secondary lumen 30.Optionally, the housing 28 may also include one or more seals (notshown), e.g., a hemostatic seal, for sealing the primary lumen 26 whileaccommodating inserting a needle, guidewire, occlusion member, or otherinstrument (not shown) into the lumen 26, e.g., preventing bodilyfluids, such as blood, from escaping proximally through the deliverysheath 12, as is known in the art.

A section of flexible tubing 36 may be connected to or otherwise extendfrom the side port 32 to a luer lock adapter 38, a manual shut-off valve(not shown), and/or other connector (also not shown), e.g., tofacilitate connecting tubing and the like (also not shown) to the sideport 32. For example, a source of sealing compound, such as thedual-syringe assembly 40 described below, may be connected to the luerlock adapter 38 before or during a procedure.

In alternative embodiments, the delivery sheath may be a tubular memberincluding a single lumen (not shown), which may include a hub, sideport, and/or other components, similar to the embodiment describedabove. Additional infatuation on such delivery sheaths may be found inco-pending application Ser. No. 10/454,362, filed Jun. 4, 2003 and Ser.No. 10/745,946, filed Dec. 24, 2003. The entire disclosures of thesereferences and any others cited therein are expressly incorporatedherein by reference.

Returning to FIG. 1, the occlusion member 16 may include an elongatewire member or other tubular body 50 carrying a balloon or otherexpandable member 58. The wire member 50 generally includes a proximalend 52, a distal end 54, and a lumen 56 extending at least partiallybetween the proximal and distal ends 52, 54. The wire member 50 may havean outer diameter of about 0.008 to 0.038 inch, e.g., not more thanabout 0.40 inch. The wire member 50 may be substantially flexible orsemi-rigid, e.g., to allow the wire member 50 to curve, bend, orotherwise adapt to anatomy through which it is advanced, yet havesufficient column strength to accommodate advancing the distal end 54 bypushing on the proximal end 52.

In one embodiment, the wire member 50 may be formed from one or morewire coil(s) (not shown) wound into an elongate tubular shape, similarto a guidewire. The wire coil(s) may be formed from one or moresubstantially round, square, or flat wires, e.g., made from stainlesssteel, Nitinol, or other metal. Thus, the wire member 50 may besubstantially flexible yet may be pushed form the proximal end 52without substantial risk of kinking or buckling.

The wire member 50 may include material applied to the wire coil(s),e.g., a polymer or other coating, to create a substantially nonporouswall such that fluid may be contained within the lumen 56 withoutsubstantial leaking. For example, a liquid polymer or other material maybe applied to the outer and/or inner surfaces of the wire coil(s), e.g.,by dipping the entire wire coil(s), brushing, and/or spraying materialonto the coiled wire(s), or by applying a coating to the wire(s) usingsuch methods before the wire(s) are formed into the wire coil(s). Ifappropriate, the coating material may be cured or otherwise solidifiedusing known procedures. Thus, coating material may have sufficientflexibility to allow the wire coil(s) to flex as the wire member 50bends while maintaining the coating integrity and nonporous wall.

In another embodiment, the wire member 50 may be formed from asolid-walled tube, such as a section of thin-walled hypo-tube. Exemplarymaterials for the wire member 50 include stainless steel, Nitinol, orother metal, polyimide or other plastic tubing, and/or compositematerials.

Returning to FIG. 1, with additional references to FIGS. 2A and 2B, theballoon 58 may be expandable from a collapsed state (such as that shownin FIG. 1) to an enlarged state (such as that shown in FIG. 3A). Forexample, saline, air, or other fluid may be introduced into an interior59 of the balloon 58 to expand the balloon 58 from the collapsed stateto the enlarged state.

In one embodiment, the balloon 58 may be formed from a flexible,substantially inelastic material, e.g., a nonelastomeric material, suchas PET, nylon, polyethylene, polyurethane, PEBAX, and the like. Thus,the balloon 58 may be substantially noncompliant or semi-compliant,thereby expanding to a predetermined size once a minimum pressure isintroduced into the interior 59 of the balloon 58. Alternatively, theballoon 58 may be formed from an elastic material, such that the size ofthe balloon 58 in the expanded state is dependent upon the pressure orvolume of fluid delivered into the balloon 58. Additional information onballoons that may be used are disclosed in co-pending application Ser.No. 10/454,362, incorporated above, and Ser. No. 10/806,927, filed Mar.22, 2004, the entire disclosure of which is also expressly incorporatedherein by reference.

As shown in FIG. 2A, the balloon 58 may be an enclosed expandable bodywith an open end 58 a. The open end 58 a may be attached to the distalend 54 of the wire member 50 such that the balloon 58 extends distallyfrom the distal end 54 of the wire member 50. For example, the end 58 amay be bonded to the distal end 54 and/or may be attached using a band(not shown) secured around the distal end 54 and the open end 58 a ofthe balloon 58. The interior 59 of the balloon 58 thereby communicateswith the lumen 56 of the wire member 50 such that fluid from the lumen56 may be used to expand the balloon 58, as explained further below.Alternatively, as seen in FIGS. 5A and 5B, an occlusion member 116 mayinclude a balloon 158 disposed proximal to a distal tip 155 of theocclusion member 116, as described further below.

Returning to FIG. 1, with additional reference to FIGS. 2A-2C, the wiremember 50 may include one or more ports or other openings 53 located inan intermediate region of the wire member 50. The port(s) 53 may simplybe one or more holes fowled in the side wall of the wire member 50,e.g., by laser cutting, drilling, etching, and the like. The port(s) 53communicate with the lumen 56, e.g., allowing a fluid source (not shown)to communicate with the lumen 56 from the outside environmentsurrounding the wire member 50.

The wire member 50 also includes a rod, tube, or other piston 60slidable into and out of the lumen 56 from the proximal end 52 of thewire member 50. The piston 60 may be an elongate member including aproximal end 62, and a distal end 64 that is axially moveable within thelumen 56 of the wire member 50. The piston 60 may be pushed or pulled,e.g., to either advance or retract the distal end 64 within the lumen 56of the wire member 50.

The piston 60 may be formed from a substantially flexible or semi-rigidmaterial, similar to the wire member 50, e.g., having sufficient columnstrength to allow the distal end 64 to be advanced into the wire member50 by pushing on the proximal end 62. For example, the piston 60 may bean elongate wire coil, similar to the wire member 50, or alternatively asolid wire or other filament. In one embodiment, the piston 60 may havea substantially uniform profile along its entire length, e.g., having adiameter between about 0.005 to 0.035 inch, such that the distal end 64may be slidably received in the lumen 54 of the wire member 50.

Optionally, a lubricous, low-friction, or other coating (not shown) maybe applied to an exterior surface of the piston 60, e.g., on at leastthe distal end 64. In addition or alternatively, a similar or differentcoating (also not shown) may be applied to at least a portion of aninterior surface of the wire member 50. The coating may reduce orincrease the force needed to cause axial movement of the piston 60within the lumen 56 of the wire member 50, depending upon the resistancedesired.

A fluid-tight seal may also be provided between the piston 60 and thewire member 50, e.g., to substantially seal the lumen 56 of the wiremember 50 such that fluid within the lumen 56 may not leak between thewire member 50 and the piston 60, e.g., proximally out the proximal end52 of the wire member 50. For example, as shown in FIGS. 1 and 2A-2D, aseal 68 may be provided on the distal end 64 of the piston 60, e.g.,attached to the distal end 64 and/or disposed on an exterior of thepiston 60 at or adjacent the distal end 64. In addition oralternatively, a seal 57 may be provided on an interior surface of thewire member 50. The seals 57 and/or 68 may provide a fluid-tight sealinside the wire member 50 to retain fluid within the lumen 56 andballoon 58 once the distal end 64 of the piston 60 has moved distallypast the port(s) 53, as described further below.

Optionally, as seen in FIG. 1, the occlusion member 16 may also includea retaining sheath or other constraint 17 slidable over the wire member50, e.g., for maintaining the balloon 58 in its collapsed conditionand/or for facilitating advancing the occlusion member 16 into apuncture through tissue. For example, the retaining sheath 17 may be anelongate tubular member including proximal and distal ends, and a lumenextending therebetween. A hub may be located on the proximal end, e.g.,to facilitate manipulating the retaining sheath 17. The retaining sheath17 may have a diameter or other size to allow the distal end to beinserted into and/or through the primary lumen 26 of the delivery sheath12. The hub of the retaining sheath 17 may be larger than the size ofthe primary lumen 26, e.g., to provide a stop limiting distaladvancement of the retaining sheath 17 into the delivery sheath 12. Theretaining sheath 58 may be sufficiently flexible to conform to thesurrounding anatomy, e.g., when the retaining sheath 58 is inserted intoor removed from a puncture, e.g., along with other components.

Referring to FIG. 2A, in one embodiment, the wire member 50 may includea tapered region 55 located proximal to the balloon 58. Correspondingly,the distal end 64 of the piston 60 may include a shoulder or tapereddistal tip 66 angled to conform to the tapered region 55 of the wiremember 50. The tapered region 55 may act as an abutment to limitadvancement of the piston 60 within the wire member 50. In addition, theshoulder 66 may engage the tapered region 55, e.g., by friction orinterference fit, to restrict proximal movement of the piston 60relative to the wire member 50, as explained further below.

Further, this configuration may provide tactile feedback to the user,e.g., that the balloon 58 has been fully expanded. For example, thetapered region 55 may be provided a predetermined distance from theport(s) 53, thereby defining a volume of fluid within the lumen 56 thatmay be directed into the balloon 58 when the distal end 64 of the piston60 is advanced from its loaded position (described below) intoengagement with the tapered region 55. The volume that is displaced maybe determined to be the desired volume for sufficiently inflating andexpanding the balloon 58.

In alternative embodiments, the piston 60 and/or wire member 50 mayinclude other lock elements (not shown) for securing the piston 60relative to the wire member 50. For example, the piston 60 may includeone or more ramps, tabs, or other detents (not shown), e.g., on thedistal end 64, and the wire member 50 may include one or more matingramps, tabs, or other detents (also not shown), e.g., within the lumen56. When the piston 60 is advanced a predetermined distance into thewire member 50, e.g., until the distal end 64 of the piston 60 isdisposed adjacent to the distal end 54 of the wire member 50 butproximal to the balloon 58, the detents may interlock, preventing thepiston 60 from being withdrawn proximally.

For example, the lock element(s) may act as a ratchet, e.g., allowingthe piston 60 to be advanced distally but not retraced proximally untila final distal position is attained. Such lock element(s) may alsoprovide tactile and/or audio feedback to the user, allowing the user todetermine when the piston 60 has reached a desired position, e.g.,corresponding to complete expansion of the balloon 58, as describedfurther below. Optionally, the lock element(s) may be overcome bypulling on the piston 60, e.g., using a predetermined force sufficientto disconnect or even break the lock securing the piston 60. Once thelock is broken, the lock elements may prevent the piston 60 from beingreinserted into the wire member 50, e.g., to prevent reuse of theocclusion member 16.

Turning to FIGS. 2C and 2D, a fluid loading device or housing 70 isshown for loading fluid into the lumen 56 of the wire member 50. In theembodiment shown, the fluid loading device 70 includes a barrel or otherhousing 71 including first and second ends 72, 74, and a lumen 76extending between the first and second ends 72, 74. The housing 71 alsoincludes a side port 77 communicating with the lumen 76. In addition,the fluid loading device 70 includes a source of vacuum and/or a sourceof fluid, such as one or more syringes (one syringe 78 shown)connectable to the side port 77 by tubing 79. The fluid within thesyringe 78 may be a substantially incompressible liquid, such as water,saline, and the like, or a gas, such as air, nitrogen, carbon dioxide,and the like.

The housing 71 has a size such that the housing 71 may be receivedaround the occlusion member 16, e.g., by inserting one end of the wiremember 50 into the lumen 76 of the housing 70. The housing 71 mayinclude one or more seals to provide a fluid-tight seal between thehousing 71 and the wire member 50. As shown, the housing 71 includes anannular seal 73, 75 adjacent each of the first and second ends 72, 74 ofthe housing 71, i.e., extending from an internal surface of the housing71 against the external surface of the wire member 50.

Turning to FIGS. 2A-2D, a method is shown for loading fluid into theocclusion member 16 using the fluid loading device 70, e.g., before orduring a medical procedure. As shown in FIG. 2A, the wire member 50 andpiston 60 may be provided separately initially, e.g., in a kit alongwith one or more other components of the system 10, such as the fluidloading device 70 and/or the other components described herein.Alternatively, the occlusion member 16 may be provided at leastpartially assembled, e.g., using one of the procedures described below,which may be performed at a manufacturing location or at one or moreother locations between the original manufacturing facility and the siteof a procedure where the occlusion member 16 may be used.

Turning to FIG. 2B, the occlusion member 16 may be assembled byinserting the distal end 64 of the piston 60 into the proximal end 52 ofthe wire member 50. Consequently, the piston 50 may be directed into thelumen 56, e.g., until the distal end 64 of the piston 60 is locatedproximal to the port(s) 53 in the wire member 50.

The housing 71 of the fluid loading device 70 may then be directed overthe wire member 50. The seals 73, 75 of the housing 71 may slide alongthe exterior surface of the wire member 50 as the housing 71 is directedalong the wire member 50. When the housing 71 overlies the port(s) 53,the seals 73, 75 may straddle the port(s) 53 such that the lumen 76 ofthe housing 71, and consequently the side port 77, communicate with thelumen 56 of the wire member 50 via the port(s) 53. Alternatively, thepiston 60 may be advanced into the wire member 50 after the housing 71is placed around the wire member 50 over the port(s) 53, e.g., until thedistal end 64 is disposed proximal to the port(s) 53.

With the housing 71 and piston 60 loaded on and in the wire member 50,the lumen 56 of the wire member 50 may contain air or other gases. Thesegases may be evacuated from the lumen 56 by connecting a source ofvacuum to the side port 77 of the housing 71. For example, a syringe 78may be connected, e.g., by tubing 79 to the side port 77. The syringe 78may then be drawn to substantially aspirate the air from within thelumen 56 of the wire member 50. Alternatively, a vacuum line and thelike (not shown) may be used to evacuate the air out of the lumen 56 andballoon 58. Once the air is evacuated from the lumen 56, a valve (notshown) on the tubing 79 or a connector on the side port 77 (not shown)may be closed to maintain the vacuum within the lumen 56.

A source of fluid, e.g., another syringe filled with fluid (representedby syringe 78, although a different syringe may be used), may be coupledto the side port 77, e.g., via tubing 79 for delivering fluid into thelumen 56 of the wire member 50. The syringe 78 may be depressed todeliver sufficient fluid into the lumen 56 via the port(s) 53 tosubstantially fill the lumen 56. The fluid is preferably delivered intothe lumen 56 in such a manner so as to not cause deployment or expansionof the balloon 58, i.e., such that the balloon 58 remains substantiallycollapsed.

Once the lumen 56 has been sufficiently filled with fluid, the piston 60may be advanced distally until the distal end 64 is disposed distal tothe port(s) 53. Because of the seal 68 on the piston 60, the lumen 56and interior 59 of the balloon 58 may become substantially isolated fromthe port(s) 53 and therefore from the surroundings around the wiremember 50. The housing 71 may then be removed from around the wiremember 50, e.g., by sliding the housing 71 down and off the end of thewire member 50, without fluid leaking.

The piston 60 may only be advanced a relatively short distance, e.g.,such that the seal 68 is located just beyond the port(s) 53. This mayminimize any expansion of the balloon 58, which may occur as the piston60 displaces fluid within the lumen 56 into the interior 59 of theballoon 58. In addition or alternatively, the volume of fluid deliveredinto the lumen 56 using the fluid loading device 70 may be reducedslightly, i.e., to maintain a slight vacuum within the lumen 56. Whenthe distal end 64 of the piston 60 is advanced past the side port(s) 53,the volume displaced may correspond to the residual vacuum. This mayreduce the risk of the balloon 58 expanding undesirably when the piston60 is advanced to isolate the lumen 56.

Optionally, as shown in FIG. 2B, the occlusion member 16 may include alocking device 80, which may be used to selectively restrain the piston60 from moving axially relative to the wire member 50. As shown, thelocking device 80 may include an annular member 82 attached or otherwisefixed to the proximal end 52 of the wire member. 50. The annular member82 may include a ramped distal surface 84 leading to a recessed abutment86. The locking device 80 may also a locking ring 88 disposed distal tothe annular member 82 and slidable along an exterior surface of the wiremember 14. For example, the locking ring 88 may be directed axially,e.g., proximally, until it slidably engages the ramped distal surface 84and enters the recessed abutment 86.

The locking ring 88 may compress the annular member 82 inwardly as itslides along the ramped distal surface 84, thereby compressing theproximal end 52 of the wire member 50 inwardly against the piston 55,e.g., to crimp the wire member 50 against the piston 60 or otherwisefrictionally engage the wire member 50 and piston 60 together. Thus,substantial axial movement of the piston 60, distally or proximally,relative to the wire member 50 may be prevented using the locking device80.

To allow movement of the piston 60, the locking ring 88 may bedisengaged from the recessed abutment 86 by pushing the locking ring 88distally out of the recessed abutment 84 and down the ramped distalsurface 86. Once the locking ring 88 is disengaged, the piston 60 may befree to move axially within the wire member 50.

Alternatively, the locking device may include other locking mechanisms,such as one or more clips, retainers, and the like that may be activatedto prevent substantial axial movement of the piston 60 relative to thewire member 50 while the locking device is engaged.

Returning to FIG. 1, the system 10 may also include a source of sealingcompound 14, such as a dual syringe assembly 40 or other delivery device(not shown), e.g., that includes two components of a sealing compound.As shown, the syringe assembly 40 includes a pair of syringe barrels 42,including outlets 43 and a plunger assembly 44 slidable into the barrels42 to cause the components therein to be delivered through the outlets43. In the embodiment shown, the plunger assembly 44 includes a pair ofplungers 45 coupled to one another that are received in respectivebarrels 42. In this manner, both plungers 45 may be manually depressedsubstantially simultaneously to deliver the components together from thesyringe barrels 42. Alternatively, a system for automatically advancingthe plungers 45 and/or otherwise delivering the components in thebarrels 42 may be used, such as those disclosed in co-pendingapplication Ser. No. 10/806,934, filed Mar. 22, 2004, the entiredisclosure of which is expressly incorporated herein by reference.

Optionally, the delivery device 14 may include a “Y” fitting 46, astatic mixer 48, and/or tubing 49, e.g., for connecting the “Y” fitting48 to outlets 43 of the barrels 42, the mixer 48 to the “Y” fitting 46and/or to the side port 32 of the delivery sheath 12, such that thesealing components ejected out of the barrels 42 may mix before beingdirected into the side port 32 of the delivery sheath 12. The outlets43, “Y” fitting 46, mixer 48, and/or tubing 49 may include cooperatingconnectors, e.g., luer lock connectors and the like (not shown), forconnecting them together.

Respective sealing components may be provided in each syringe barrel 42of the syringe assembly 40 that, when mixed together, are activated toform a hydrogel or other sealing compound. Additional information onsuch hydrogels and systems for delivering them are disclosed in U.S.Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, and 6,379,373, andin co-pending applications publication Nos. 2002-0106409 published onAug. 8, 2002, 2003-0012734 published on Jan. 16, 2003, 2002-0114775published on Aug. 22, 2002, and 2004-0249342 published on Dec. 9, 2004.The disclosures of these references and any others cited therein areexpressly incorporated by reference herein.

With continued reference to FIG. 1, the system 10 may also include anintroducer sheath 18. As shown, the introducer sheath 18 is an elongatetubular member including a proximal end 102, a distal end 104, and alumen 106 extending between the proximal and distal ends 102, 104. Theintroducer sheath 18 may terminate in a tapered distal tip 105 forfacilitating advancing the introducer sheath 18 substantiallyatraumatically through tissue into a puncture. Exemplary materials forthe introducer sheath 18 may include one or more plastics, such as FEP,polyvinyl chloride (PVC), polyamide, PEEK, nylon, PET, PEBAX, andpolyethylene, metals, such as stainless steel, and nickel titanium,and/or composite materials. The introducer sheath 18 may besubstantially rigid, semi-rigid, or substantially flexible, e.g., tofacilitate insertion through a puncture into a blood vessel or otherbody lumen. The introducer sheath 18 may have an outer diameter betweenabout 0.080 to 0.140 inch and/or a wall thickness between about 0.002 to0.10 inch.

A housing 108 may be attached to or otherwise provided on the proximalend of the introducer sheath 18. The housing may include a side port 109that communicates with an interior of the housing 108 and the lumen 106of the introducer sheath 18. A section of flexible tubing may beconnected to or otherwise extend from the side port 109, terminating ina manual shut-off valve and/or a luer lock or other connector (notshown), e.g., to facilitate connecting tubing and the like (not shown)to the side port 109. The housing 108 may also include one or more seals(not shown), e.g., a hemostatic seal, for substantially sealing thelumen of the delivery sheath 18, yet accommodating inserting one or moreinstruments (not shown) into the lumen.

Optionally, a dilator 19 may also be provided, e.g., within the lumen 86of the introducer sheath 18. The dilator 19 may also include a proximalend 112, a distal end 114 sized for insertion through the lumen of theintroducer sheath 18, a lumen 118 extending between the proximal enddistal ends, and a hub or other handle 120 on the proximal end 112. Thedistal end 114 may include a tapered or multiple ramped shape, similarto known dilators. The dilator 19 may be formed from substantiallyrigid, semi-rigid, or substantially flexible materials, similar to theintroducer sheath 18.

The dilator 19 may be loaded into the introducer sheath 18 duringmanufacturing or immediately before a procedure. In addition, thedilator 19 may be loaded into the introducer sheath 18 by inserting thedistal end 114 of the dilator 19 into the hub 108 and lumen 106 of theintroducer sheath 18 until the hubs 108, 120 abut one another. Onceinserted into the introducer sheath 18, the distal end 114 of thedilator 19 may extend beyond the distal end 104 of the introducer sheath18, e.g., to provide a gradually tapering transition for the assembly.Thus, before a procedure, the dilator 19 and introducer sheath 18 may bedisposed concentrically around one another in an assembly, as shown inFIG. 1. Optionally, the dilator 19 may be eliminated, if desired.

In one embodiment, a flexible and/or thin-walled sleeve 20, similar tothose disclosed in U.S. application Ser. No. 11/112,970, entitled“Apparatus and Methods For Facilitating Access Through A PunctureIncluding Sealing compound Therein,” filed Apr. 22, 2005, may also beused in connection with the introducer sheath 18. The entire disclosureof this application is expressly incorporated by reference herein.

Turning to FIGS. 3A-3C and 4A-4C, a method is shown for delivering anintroducer sheath (and/or sleeve), such as the introducer sheath 18described above, into a passage 90 extending through tissue 96. In theillustrated embodiment, the passage 90 is a percutaneous punctureextending from a patient's skin 92 to a blood vessel or other body lumen94. For example, the vessel 94 may be a peripheral artery, e.g., afemoral artery, a carotid artery, and the like. It will be appreciatedthat systems and methods constructed and undertaken as described hereinmay be used to seal other passages through tissue within a patient'sbody.

Initially, as shown in FIGS. 3A-3C, the puncture 90 may be created andsealing compound 99 may be delivered into the puncture 90. Turning toFIG. 2A, to create the puncture 90, a hollow needle 15 may be insertedthrough the patient's skin 92 and intervening tissue 96 into the vessel94. The occlusion member 16, e.g., with the wire member 50 loaded withthe piston 60 sealing fluid therein, may be inserted into the puncture90, e.g., through the needle 15 until the distal tip 66 is disposedwithin the vessel 94. Optionally, as shown, the retaining sheath 17 maycover the balloon 58 on the wire member 50 as the occlusion member 16 isadvanced through the needle 15, thereby maintaining the balloon 58 inthe contracted or collapsed condition.

Turning to FIG. 2B, once the balloon 58 is located within the vessel 94,the needle may be removed, and the balloon 58 may be expanded within thevessel 94. For example, the retaining sheath 17 may be retractedcompletely (or only partially) out of the puncture 90 to expose theballoon 58 within the vessel 84.

The balloon 58 may then be expanded within the vessel 94. For example,as shown in FIG. 2B, the piston 60 may be advanced distally relative tothe wire member 50. As the piston 60 is advanced within the wire member50, fluid within the lumen 56 may enter the interior 59 of the balloon58, causing the balloon 58 to expand. As described above, the wiremember 50 and/or piston 60 may include one or more elements that tactileand/or audio feedback to provide an indication that the piston 60 hasbeen advanced to a position where the balloon 58 is fully expanded.

Turning to FIG. 3C, with the balloon 58 fully expanded, a deliverysheath, such as the delivery sheath 12 described above, may be advancedover the occlusion member 16 into the puncture 90, e.g., before or afterthe balloon 58 is expanded. For example, the proximal end 62 of thepiston 60 may be backloaded into the distal end 24 of the deliverysheath 12, and then the delivery sheath 12 may be advanced over thepiston 60 and wire member 50 until the distal end 24 enters the vessel94. Because of the substantial uniformity in cross-section and size ofthe piston 60 and wire member 50, the delivery sheath 12 may pass easilyover the occlusion member 16. Alternatively, the proximal end 52 of thewire member 50 may include a transition, e.g., a ramped proximal edge(not shown) to facilitate advancing the delivery sheath 12 over the wiremember 50.

In one embodiment, the delivery sheath 12 may be advanced until thedistal end 24 is disposed within the vessel 94. The balloon 58 may thenbe expanded (if not expanded before introducing the delivery sheath 12),and the occlusion member 16 may be partially retracted until the balloon58 contacts the distal end 24 of the delivery sheath 12 (providing afirst tactile feedback). The occlusion member 16 may be retracted bypulling on the proximal end 52 of the wire member 50 unless the piston60 is locked relative to the wire member 50, whereupon the piston 60 maybe pulled. Otherwise, the piston 60 may be refracted relative to thewire member 50, which may prematurely deflate the balloon 58 or evenrelease the fluid within the lumen 56 of the wire member 50.

The occlusion member 16 may then be pulled further until the balloon 58contacts the wall of the vessel 94 (providing a second tactilefeedback), thereby partially in retracting the delivery sheath 12 backinto the puncture 90, e.g., until the distal end 24 is disposed adjacentthe vessel 94.

Alternatively, the occlusion member 16 may be retracted until theocclusion element 51 contacts the wall of the vessel 94 before thedelivery sheath 12 is introduced. The delivery sheath 12 may then beadvanced into the puncture 90 until the distal end 24 contacts theexpanded balloon 58, thereby providing tactile feedback that the outlets25 of the delivery sheath 12 are disposed within the puncture 90proximal to the vessel 94.

With continued reference to FIG. 3C, a source of sealing compound 14,e.g., the dual syringe assembly 40 described above, may be prepared andconnected to the side port 32 of the delivery sheath 12, e.g., viatubing 49, either before or after the delivery sheath 12 is advancedinto the puncture 90. The sealing compound 99 may then be deliveredthrough the secondary lumen 30 and the outlets 25 and into the puncture90. The sealing compound 99 may flow radially outwardly to permeate atleast partially into the tissue surrounding the puncture 90.

Optionally, the delivery sheath 12 may be retracted as the sealingcompound 99 is delivered, e.g., to fill the puncture 90 along itslength. Additional apparatus and methods for delivering the sealingcompound 99 into the puncture 90 around the occlusion member 16 aredisclosed in co-pending application Ser. Nos. 10/454,362 and 10/745,946,incorporated above, or in co-pending application Ser. No. 10/975,205,filed Oct. 27, 2004, the entire disclosure of which is expresslyincorporated by reference herein.

Once a desired amount of the sealing compound 99 is delivered into thepuncture 90, the occlusion member 16 may be maintained such that theballoon 58 continues to seal the puncture 90 from the vessel 94, e.g.,for sufficient time for the sealing compound 99 to at least partially orcompletely cure. Thereafter (or immediately after filling the puncture90), the delivery sheath 12 may be removed entirely from the puncture90.

The balloon 58 may then be deflated and the occlusion member 16 may beremoved from the vessel 94 and puncture 90. In one embodiment, theballoon 58 may be deflated by moving the piston 60 proximally relativeto the wire member 50. This action may withdraw the fluid within theinterior 59 of the balloon 58 back into the lumen 56 of the wire member50, thereby substantially collapsing the balloon 58. With the balloon 58collapsed, the occlusion member 16 may simply be pulled proximally outthrough the puncture 90.

If the piston 60 is locked relative to the wire member 50, the lock (notshown) may need to be disengaged. Alternatively, if the lock is notreleasable, the piston 60 may be pulled with sufficient force to breakthe lock. Optionally, the piston 60 may be removed entirely from thewire member 50, thereby releasing the fluid within the lumen 56 of thewire member 50 and exposing the lumen 56 and interior 59 of the balloon58 to the ambient pressure of the surroundings.

The wire member 50 may be withdrawn before or after removing thedelivery sheath 12. If the delivery sheath 12 remains within thepuncture 90 while the wire member 50 is removed, the balloon 58 may beforced to collapse as it enters the delivery sheath 12. If the pistonhas been removed or withdrawn proximally beyond the side port(s) 53 inthe wire member 50, this action may force any residual fluid within theballoon 58 out of the balloon 58 and out the side port(s) 53 and/orproximal end 52 of the wire member 50.

Optionally, turning now to FIGS. 4A-4C, an introducer sheath 18 and/orflexible sleeve 20, such as those described above and disclosed in theabove-incorporated ACI-010 application, may be delivered into thepuncture 90 and/or through the sealing compound 99. The sleeve 20 mayprevent sealing compound 99 from separating and/or otherwise beingreleased during introduction of the introducer sheath 18, as explainedfurther below. Alternatively, the sleeve 20 may be omitted entirely.

As shown in FIG. 4A, the wire member 50 (or the entire occlusion member16) may remain within the puncture 90 and vessel 94 after delivering thesealing compound 99. Optionally, the balloon 58 (not shown) may remainexposed and/or expanded, or the optional retaining sheath 17 (also notshown) may be advanced over the wire member 50 to cover and/or collapsethe balloon 58. Alternatively, the wire member 50 may be removed fromthe puncture 90 and a separate guidewire (not shown), e.g., withoutballoon 58, may be advanced through the puncture 90 into the vessel 94in place of the wire member 50.

Turning to FIG. 4B, the introducer sheath 18, dilator 19, and sleeve 20may then be introduced into the puncture 90, e.g., over the wire member50 (or the entire occlusion member 16). For example, the proximal end 52of the wire member 50 and/or the proximal end 62 of the piston 60 may bebackloaded into the introducer sheath 18 before the introducer sheath 18is advanced into the puncture 90. Optionally, hub 122 of the sleeve 20may be placed against or immediately above the patient's skin 92overlying the puncture 90.

Turning to FIG. 4C, the introducer sheath 18 (and any of the dilator 19and/or sleeve 20 carried therein) may then be advanced into the puncture90, e.g., until the distal end 104 of the introducer sheath 18 isdisposed within the vessel 94. As the introducer sheath 18 is advanced,the sleeve 20 may unfurl from the introducer sheath 18 and becomeexposed within the puncture 90, e.g., everting and surrounding theexterior of the introducer sheath 18. In the embodiment shown, thelength of the sleeve 20 is shorter than the introducer sheath 18 suchthat the free end of the sleeve 20 is disposed proximal to the distalend of the introducer sheath 18 and may not extend into the vessel 94.

The dilator 19 and/or tubular member (not shown) may be withdrawnthrough the introducer sheath 18 from the puncture 90, e.g., together orsuccessively, leaving the introducer sheath 18 and sleeve 20 within thepuncture 90. The wire member 50 (or entire occlusion member 16) may alsobe removed along with, before, or after the dilator 19 and/or tubularmember, e.g., after collapsing the balloon 58 (not shown).Alternatively, if the balloon 58 is still expanded, the wire member 50may be removed, causing the introducer sheath 18 or dilator 19 tocollapse the balloon 58 towards the collapsed state as it enters thelumen of the introducer sheath 18.

Once the distal end of the introducer sheath 18 is disposed within thevessel 94, one or more instruments (not shown) may be advanced throughthe introducer sheath 18 into the vessel 94, e.g., to perform one ormore diagnostic and/or interventional procedures within the patient'sbody, as is known to those skilled in the art. The sleeve 20 generallydoes not interfere with the introduction of such instruments, since itis located only around the introducer sheath 18.

Optionally, if the sleeve 20 includes any weakened seams, the sleeve 20may be removed from around the introducer sheath 18 to provide aconventional introducer sheath arrangement for the subsequent procedure.For example, the sleeve 20 may separate into two or more pieces, e.g.,along one or more predetermined seams (not shown). Thus, conventionalprocedures may be used without need for extra attention to the sleeve20.

Upon completing any such procedures, the instrument(s) may be removedfrom the vessel 94 through the introducer sheath 18. The introducersheath 18 and sleeve 20 (if remaining around the introducer sheath 18)may then be removed from the vessel 94 and puncture 90, e.g.,simultaneously or successively. The sealing compound 99 and/or tissuemay recoil sufficiently to substantially fill the puncture 90, therebyallowing and/or encouraging hemostasis to occur between the vessel 94and puncture 90. Optionally, external pressure may be applied to thepatient's skin 92 during removal of the introducer sheath 18, e.g., tofurther enhance sealing of the puncture 90 until hemostasis occurs.

Turning to FIGS. 5A and 5B, another embodiment of an occlusion member116 is shown that may be included in a system, e.g., instead of theocclusion member 16 described above. The occlusion member 16 generallyincludes an elongate wire member or other tubular body 150 carrying aballoon or other expandable member 158. Similar to the previousembodiment, the wire member 150 includes a proximal end 152, a distalend 154, and a lumen 156 extending at least partially between theproximal and distal ends 152, 154. The wire member 150 may have an outerdiameter or other cross-section between about 0.008-0.038 inch, e.g.,not more than about 0.040 inch.

The wire member 150 may be substantially flexible or semi-rigid, e.g.,to allow the wire member 150 to curve, bend, or otherwise adapt toanatomy through which it is advanced, yet have sufficient columnstrength to accommodate advancing the distal end 154 by pushing on theproximal end 152. The wire member 150 may be formed from one or morewire coil(s) (not shown) wound into an elongate tubular shape,optionally, including applied to the wire coil(s) to create asubstantially nonporous wall or may be formed from a solid-walled tube,similar to the previous embodiment.

The balloon 158 may be expandable from a collapsed state (such as thatshown in FIG. 5B) to an enlarged state (such as that shown in FIG. 5A),e.g., by introducing fluid into an interior 159 of the balloon 158. Theballoon 158 may be formed from a flexible, substantially inelasticmaterial, e.g., to provide a substantially noncompliant orsemi-compliant balloon 159 that expands to a predetermined size, or theballoon 158 may be formed from an elastic material, such that the sizeof the balloon 158 depends upon the pressure or volume of fluiddelivered into the balloon 158.

As shown, the balloon 158 is disposed proximal to a distal tip 155 ofthe occlusion member 116, as described further below. For example, theballoon 158 may include a first end 158 a attached to a distal end 154of a wire member 150 and a second end 158 b attached to the distal tip155. The distal tip 155 may be a rounded, tapered, and/or substantiallyblunt member providing a substantially atraumatic tip, e.g., including a“J” tip (not shown), if desired to facilitate advancement.

As shown, the proximal end 152 of the wire member 150 is substantiallyclosed, e.g., by providing a plug, sealant, glue, or other seal materialin the proximal end 152. Alternatively, the proximal end 152 may becapped using a cap or other element (not shown). Thus, the lumen 156 maybe substantially isolated from the region surrounding the wire member150.

To communicate with the lumen 156, the wire member 150 may include oneor more ports or other openings 153 located in an intermediate region ofthe wire member 150, e.g., adjacent the proximal end 152. The port(s)153 may communicate directly with the lumen 156, e.g., allowing a fluidsource (not shown) to communicate with the lumen 156 from the outsideenvironment surrounding the wire member 150, as described further below.

The occlusion member 116 may also include a spring or biasing mechanism,such as spring wire 160 within the lumen 156 or otherwise coupled to thewire member 150. The spring wire 160 may be formed from an elastic orsuperelastic material, e.g., stainless steel or Nitinol, that may besufficiently flexible to bend within the wire member 150, yet havesufficient column strength to bias the spring wire 160 to extendaxially. The spring wire 160 may be a solid wire, e.g., having a roundor flat cross-section. Optionally, one or more other biasing mechanisms(not shown) may be provided or the biasing mechanism may be omitted.

The spring wire 160 may be an elongate member including a proximal end162 that is fixed relative to the wire member 150, and a distal end 164that is fixed relative to the distal tip 155. For example, the proximalend 162 of the spring wire 160 may be attached to the proximal end 162of the wire member 150, e.g., using an adhesive, sonic or other welding,embedding the proximal end 162 in the seal material, and the like. Thedistal end 164 of the spring wire 160 may be similarly attached to thedistal tip 155 or alternatively to the distal end 158 b of the balloon158.

The relative lengths and fixation points of the wire member 150 and thespring wire 160 may place the spring wire 160 under slight tensioninside the wire member 50, thereby biasing the distal tip 155 away fromthe distal end 154 of the wire member 150. This may place the balloon158 under tension, thereby minimizing the cross-section of the balloon158 in the collapsed state. This bias provided by the spring wire 160may facilitate collapsing the balloon 158 after a procedure, e.g., tofacilitate withdrawing the balloon 158 from a puncture 90 (not shown),as described further below.

Turning to FIG. 3A, when fluid is delivered into the interior 159 of theballoon 158, e.g., using the devices and/or methods described furtherbelow, the balloon 158 may shorten as it expands. Consequently, this mayplace the spring wire 160 under a compressive stress, foreshortening thedistance between the proximal and distal ends 162, 164 of the springwire 160. To reduce the resulting stress, the spring wire 160 maypartially coil or otherwise contort inside the lumen 156 of the wiremember 150. This may cause the wire member 150 to curve or otherwisetwist to reduce the stress imposed by the spring wire 160 when the wiremember 150 is free from outside forces or constraints (such as tissuesurrounding a puncture).

When fluid 54 is evacuated from the interior of the balloon 158, theballoon returns towards the collapsed state of FIG. 5B. This may releasethe compressive force on the spring wire 160, whereupon the spring wire160 may resiliently extend, i.e., move the distal end 164 distally awayfrom the proximal end 162. This may bias the balloon 158 to extenddistally, i.e., elongate, as it returns towards the collapsed state,thereby minimizing the profile of the balloon 158.

Turning to FIG. 6, an exemplary embodiment of a fluid loading device 170is shown for delivering fluid into and out of the lumen 156 of the wiremember 150, e.g., via the one or more side port(s) 153. The fluid may beused to selectively expand and/or collapse the balloon 58, similar tothe embodiments described above. Generally, the fluid loading device 170includes a housing 171 receivable on the proximal end 152 of the wiremember 150, and a connector 179 for connecting to a source of vacuum orfluid, such as syringe 178, to the housing 171.

As shown, the housing 171 includes a proximal end 172 including theconnector 179 thereon, a distal end 174, and a lumen or chamber 176extending at least partially between the proximal and distal ends 172,174. The distal end 174 is substantially open, having a size forreceiving the proximal end 152 of the wire member 150 therein throughthe distal end 174 of the housing 171. The housing 171 may also includea shut-off mechanism 173 for selectively isolating or accessing thechamber 176 from the proximal end 172 of the housing 171.

The housing 171 has a sufficient length such that, when the housing 171is advanced onto the proximal end 152 of the wire member 150, the distalend 174 of the housing 171 extends distally beyond the side port(s) 153in the wire member 150. Thus, the side port(s) 153 in the wire member150 may communicate with the chamber 176 around the proximal end 152 ofthe wire member 150. Optionally, the housing 171 may include a seal 175,such as a septum, o-ring, and the like, disposed within the distal end174 of the housing. The seal 175 may be able to slide along the exteriorof the wire member 150, yet create a substantially fluid-tight sealbetween the exterior of the wire member 150 and the distal end 174 ofthe housing 171.

The shut-off mechanism 173 may include a manual stopcock that may berotated to allow a passageway therein to communicate between theproximal end 172 and the chamber 176 or isolate the chamber 176 from theproximal end 172 depending on its orientation (shown as open in FIG. 6).Alternatively, a valve or other manual or actuated shut-off mechanism(not shown) may be provided instead of the stopcock. The connector 179may be a male or female Luer lock connector, or other connector forremovably engaging with the syringe 178. Alternatively, the connector179 and shut-off mechanism 173 may be replaced by a penetrable seal (notshown), e.g., which may be penetrated by a needle (also not shown) onthe syringe 178.

Optionally, a locking mechanism (not shown) may be provided for securingthe housing 171 to the proximal end 152 of the wire member 150. Forexample, a clamp or other device may be provided that may be tightenedaround the distal end 174 of the housing 171. Alternatively, the housing171 may be sufficiently secured over the wire member 150 by friction oran interference fit.

Still referring to FIG. 6, during use, the housing 171 may be advancedonto the wire member 150, and a syringe 178 may be connected to theconnector 179. With the shut-off mechanism 173 open, the syringe 178 maybe drawn to evacuate substantially the air out of the lumen 156 of thewire member 150 and/or out of the interior 159 of the balloon 158.Fluid, e.g., saline or water, may then be delivered into chamber 176,and consequently into the lumen 156 and the interior 159 of the balloon158 to expand the balloon 158. The shut-off mechanism 173 may be closed,and the syringe 178 may be disconnected, leaving the housing 171 on theproximal end 152 of the wire member 150.

When it is desired to collapse the balloon 158, the shut-off mechanism173 may be opened, thereby allowing the fluid within the lumen 156 andthe interior 159 of the balloon 158 to escape, e.g., to equalize thepressure within the balloon 158 to the surrounding ambient pressure.Alternatively, a syringe 178 or other source of vacuum may be connectedto the connector 179, and the fluid may be evacuated actively fromwithin the balloon 178 to collapse the balloon 178.

During a procedure, such as the sealing procedure described above, theocclusion member 116 may be advanced into a puncture (not shown), e.g.,by introducing the distal end 154 of the wire member 150 into thepuncture with the balloon 158 collapsed until the balloon 158 isdisposed within a blood vessel (also not shown) accessed via thepuncture. The occlusion member 116 may be advanced through a needle (notshown) used to create the puncture or through a delivery sheath (alsonot shown) already placed in the puncture. If a delivery sheath is notalready in place, the delivery sheath may be advanced over the occlusionmember 116, e.g., by backloading the proximal end 152 of the wire member150 into the delivery sheath lumen.

The housing 171 may then be attached to the proximal end 152 of the wiremember 150, which should be extending from the proximal end of thedelivery sheath. Alternatively, the housing 171 may be attached to theproximal end 152 of the wire member 150 before the delivery sheath isintroduced if the cross-section of the housing 171 is small enough topass through the delivery sheath lumen.

The syringe 178 or other source of fluid may then be connected to thehousing 171, e.g., after opening the shut-off mechanism 173, and fluidmay be directed into the lumen 156 of the wire member 150 via thechamber 176 of the housing 171. Sufficient fluid may be introduced intothe lumen 156 of the wire member 150 to substantially expand the balloon158 to the enlarged state.

The expanded balloon 158 may then be used to seal the vessel from thepuncture, e.g., by at least partially retracting the occlusion member116 until the balloon 158 substantially engages the wall of the vessel.Sealing compound may then be delivered into the puncture via thedelivery sheath, similar to the embodiments described above. Optionally,once sufficient sealing compound has been delivered into the puncture,the delivery sheath may be withdrawn from the puncture, and anintroducer sheath (not shown) may be advanced over the occlusion member116 into the puncture.

The balloon 158 may be collapsed and/or removed from the puncture, e.g.,before or after placing the introducer sheath in the puncture. Tocollapse the balloon 158, the shut-off mechanism 173 may simply beopened, thereby allowing fluid to pass out of the interior 159 of theballoon 158, through the lumen 156, and possibly out of the proximal end172 of the housing 171. Fluid may be affirmatively evacuated from withinthe balloon 158, or, with the shut-off mechanism 173 open, the occlusionmember 116 may be withdraw, causing the balloon 158 to collapse as itpulled into the lumen of the introducer or delivery sheath.

While the above-described occlusion members have been described inconnection with pre-sealing applications, it should be understood thatthe occlusion members described herein may be used during otherprocedures. For example, in one embodiment, an occlusion member, such asthose described above, may be inserted into a puncture through tissueafter completing a procedure that involves accessing a blood vessel orother body lumen via the puncture. Exemplary apparatus and methods foraccessing a blood vessel or other body lumen, and/or for sealing thepuncture after completing such a procedure are described in co-pendingapplication Ser. No. 10/454,362, filed Jun. 4, 2003, incorporated byreference above, and Ser. No. 10/806,952, filed Mar. 22, 2004, theentire disclosure of which is expressly incorporated by referenceherein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particularembodiments or methods disclosed, but to the contrary, the invention isto cover all modifications, equivalents and alternatives falling withinthe scope of the appended claims.

What is claimed is:
 1. An occlusion device for sealing a puncturethrough tissue, comprising: an elongate tubular member comprising aproximal end, a distal end sized for insertion into a puncture, a lumenextending at least partially between the proximal and distal ends, andan expandable occlusion element carried on a distal region of thetubular member, the occlusion element having an interior communicatingwith a distal opening in the lumen, the tubular member having asubstantially uniform diameter extending between the proximal end andthe distal region; and a fluid loading device receivable on the proximalend of the elongate tubular member for delivering fluid into, anddrawing fluid out of, the interior of the occlusion element to therebyexpand and collapse the occlusion element.
 2. The device of claim 1,wherein the fluid loading device further comprises a connector toconnect a source of fluid to a housing of the fluid loading device. 3.The device of claim 2, wherein the source of fluid is a syringe.
 4. Thedevice of claim 2, wherein the housing further comprises a shut-offmechanism having an open and a closed position.
 5. The device of claim4, wherein the open position of the shut-off mechanism allows for thesource of fluid to evacuate substantially all the air out of the lumenof the elongate tubular member and/or out of the interior of theocclusion element.
 6. The device of claim 4, wherein the closed positionof the shut-off mechanism allows for isolating fluid delivered from thesource of fluid into the lumen of the elongate tubular member and intothe interior of the occlusion element.
 7. The device of claim 1, whereinthe tubular member further comprises a port in a proximal region of thetubular member communicating with the lumen and communicating with thefluid loading device.
 8. The device of claim 1, wherein the tubularmember has an outer diameter of not more than about 0.040 inch.
 9. Thedevice of claim 1, wherein the tubular member comprises one or more wirecoils defining a substantially nonporous wall of the tubular member. 10.The device of claim 1, wherein the tubular member comprises asolid-walled tubular body defining the lumen.
 11. An occlusion devicefor sealing a puncture through tissue, comprising: an elongate tubularmember comprising a proximal end, a distal end sized for insertion intoa puncture, a lumen extending at least partially between the proximaland distal ends, a port in a proximal region of the tubular membercommunicating with the lumen, and an expandable occlusion elementcarried on a distal region of the tubular member, the occlusion elementhaving an interior communicating with a distal opening in the lumen; anda fluid loading device connectable to the proximal region of the tubularmember, such that the fluid loading device seals all sides of thetubular member and the fluid loading device communicates with the portfor delivering fluid from the fluid loading device into the lumen of thetubular member; and a syringe coupled to the fluid loading device todeliver fluid into the lumen to allow expansion and collapse of theocclusion element.
 12. The device of claim 11, wherein the fluid loadingdevice further comprises a shut-off mechanism that isolates fluid loadedinto the lumen from the fluid loading device when the shut-off mechanismis placed in the closed position.
 13. The device of claim 12, whereinfluid is released from the lumen when the shut-off mechanism is placedin the open position.
 14. The device of claim 11, wherein the tubularmember has an outer diameter of not more than about 0.040 inch betweenthe proximal end and the distal region.
 15. The device of claim 11,wherein the tubular member has a substantially uniform outercross-section such that a delivery sheath may pass easily over theocclusion device when the occlusion device is backloaded into thedelivery sheath.
 16. A method for sealing a puncture extending throughtissue from a patient's skin to a body lumen, comprising: introducing adistal end of an elongate occlusion member into the puncture until anexpandable member carried on the distal end is disposed within the bodylumen, the occlusion member comprising a substantially uniform diameterlumen extending proximally from the distal end and communicating with aninterior of the expandable member; delivering fluid into the lumen ofthe elongate occlusion member to the interior of the expandable memberto thereby expand the expandable member; retracting the occlusion memberat least partially against a wall of the body lumen to cause theexpandable member to substantially seal the body lumen from thepuncture; advancing a sheath over the proximal end of the elongateocclusion member into the puncture; and delivering sealing compound intothe puncture through the sheath.
 17. The method of claim 16, furthercomprising closing a shut-off mechanism to isolate fluid within thelumen and interior of the expandable member.
 18. The method of claim 17,further comprising collapsing the expandable member and withdrawingfluid from the interior of the expandable member and body lumen byopening the shut-off mechanism.
 19. The method of claim 16, wherein thestep of delivering fluid into the lumen further comprises providing asyringe connected to a fluid loading device attached to a proximal endof the elongate occlusion member.
 20. The method of claim 16, whereinthe elongate occlusion member has substantial uniformity incross-section such that the sheath passes easily over the elongateocclusion member when the sheath is advanced over the elongate occlusionmember.